"Not So Different": The Year in US Regulatory Activity for Biosimilars

Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.

On this episode of Not So Different, The Center for Biosimilars® discusses all the conference coverage, adalimumab data, and market insights to come out of the biosimilar dermatology space in March 2024.

Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

A Chinese company has expressed interest in developing a biosimilar to Ozempic (semaglutide); Celltrion completed its biologic license application for its omalizumab biosimilar candidate.

Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.